Primary objective: To evaluate the influence of pSS on sexual function, as measured by the female sexual function index (FSFI), in comparison to a healthy control group. Secundary objective: To evaluate the influence of pSS on subdomains of sexual…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Female sexual function index
Secondary outcome
Female sexual function index subdomain scores
o Desire
o Arousal
o Lubrication
o Orgasm
o Satisfaction
o Pain
Female sexual distress scale
RAND-36 item Health Survey
Center for epidemiologic studies depression scale
Multidimensional fatigue inventory
Maudsley marital questionnaire, marital subscale
EULAR Sjögren's syndrome patients reported index (only in patiënts)
EULAR Sjögren*s syndrome disease activity index (only in patiënts)
Disease duration and use of medication for vaginal dryness and pSS (only in
patiënts)
Menopausal status
Background summary
Sjögren*s syndrome (SS) is a chronic inflammatory and lymphoproliferative
disease with autoimmune features. SS is characterised by a progressive
lymphocytic infiltration of the exocrine glands, notably the lacrimal and
salivary glands. The main clinical features are a progressive dryness of the
eyes (keratoconjunctivitis sicca) and dryness of the mouth (xerostomia).
Furthermore, various extraglandular manifestations may develop of which
restricting fatigue is the most common.
A less known sicca symptom that can occur in SS is vaginal dryness, which can
cause dyspareunia. Several studies have shown that the prevalence of vaginal
dryness is significantly higher in SS compared to healthy controls. Beluenger
et al (2005) found that of all sicca symptoms, vaginal dryness had the highest
correlation with a reduction in quality of life. However, the influence of
vaginal dryness in primary SS on sexual function and distress has not been
studied.
Research regarding the etiology of vaginal dryness has found perivascular
inflammation in the vagina as a possible explanation for vaginal sicca
symptoms. Treatment of vaginal dryness is limited to symptomatic treatment like
the use of vaginal lubricants. Pilocarpine has been proved to be effective in
sicca symptoms of the eyes and mouth, but the effect has not been studied for
vaginal dryness. This study can provide a basis for further research on the
etiology and treatment of vaginal dryness in primary SS.
Study objective
Primary objective: To evaluate the influence of pSS on sexual function, as
measured by the female sexual function index (FSFI), in comparison to a healthy
control group.
Secundary objective: To evaluate the influence of pSS on subdomains of sexual
function, in particular vaginal lubrication. To investigate the relation
between vaginal lubrication in pSS and sexual distress and quality of life,
taking into account depression, fatigue and marital distress in pSS. To
investigate the relation between vaginal sicca symptoms and the disease
activity, use of pilocarpine, other medications and menopause.
Study design
Cross-sectional study.
Study burden and risks
The patients from the UMCG pSS cohort and the healthy controls will receive a
patient information leaflet and a form on which they can fill in if they are
interested in participation. If they send back this form in the self-adressed
envelope they will be send informed consent form and a questionnaire. This
self-administered questionnaire will comprise above named subcomponents and
will take approximately 30-40 minutes to complete. The participants will be
asked to return the questionnaire by mail in a self addressed envelope. In the
next routine visit to their regular nurse practitioner or doctor, the EULAR
Sjögren*s syndrome disease activity index will be recorded for the
patientgroup.
Hanzeplein 1
Groningen 9700 RM
NL
Hanzeplein 1
Groningen 9700 RM
NL
Listed location countries
Age
Inclusion criteria
Primary SS according to the revised European - U.S. criteria (in patients).
Female.
Age of 18-60 years.
Written informed consent.
Exclusion criteria
For healthy controls:
The presence of SS or any other autoimmune connective tissue disease such as SLE, reumatoid arthritis, scleroderma or mixed connective tissue disease.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL43183.042.13 |